- mHealth app collaborative Xcertia released a batch of industry-developed draft guidance documents meant to clarify questions around operability, privacy, security and content of mobile health apps.
- The American Medical Association founded Xcertia a year ago with the American Heart Association, HIMSS and DHX Group to foster safe and effective use of health technologies. The group is seeking feedback on the guidelines through the end of January.
- The guidance comes as use of digital apps increasingly are being used to track specific medical conditions and vital signs. Recent moves by Apple reportedly include noninvasive sensor to track blood sugar and talks to acquire Crossover Health, its on-site clinic operator. The tech giant also bought EHR startup Gliimpse a year ago.
“Cooperative input on the guidelines from consumers, developers, payers, clinicians, academia and other motivated stakeholders will provide Xcertia with guidance on where it needs to focus its efforts in 2018 to positively impact the trajectory of the mobile health industry,” Dr. Michael Hodgkins, chair of Xcertia’s board of directors, said in a statement.
Included in the guidelines are recommendations on how to assess if an app installs, loads and run in an effective and user-friendly manner and maintains a history of updates. They also discuss the protection of personal health information and HIPAA compliance and safeguards to protect devices from malware and other forms of cyberattacks.
App content should be based on more than one credible source such as evidence-based practice and peer-reviewed journals and should be written in language that is appropriate for the intended audience. Any advertisements that are included should be clearly noted.
Industry groups have stepped up to provide guidance and set some standards on digital health products in what some stakeholders feel is an absence of federal regulation. In 2016, the AMA released a set of principles intended to help physicians integrate mobile health apps, trackers and sensors into medical care.
The Food and Drug Administration is beginning to more clearly define its role in the digital health space, however. Last week, the agency issued draft guidance clarifying when it will regulate certain types of clinical and patient decision support software as a medical device. For example, the guidance exempts clinical decision support software when a physician can independently review the information on which the CDS recommendation is based.
The agency also clarified it won’t regulate mobile apps aimed solely at helping people maintain a healthy lifestyle, such as Fitbits. It also finalized guidance developed with the International Medical Device Regulators Forum meant to harmonize medical software regulation globally.